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Behavioural Intervention
tDCS for Autism
N/A
Recruiting
Led By Peter Tsai, MD, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment (approx at 3 month)
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how electric current to the brain can help improve symptoms of Autism in children.
Who is the study for?
This trial is for children and young adults aged 5 to 21 with a clinical diagnosis of Autism Spectrum Disorder (ASD). It's not suitable for those who are pregnant, have brain implants or pacemakers, any metal implants, hearing or visual impairments, a history of brain injury, or known brain/skull abnormalities unrelated to ASD.
What is being tested?
The study is examining the impact of transcranial direct current stimulation (tDCS) on challenges associated with ASD. Participants will receive either the actual tDCS treatment or a sham (placebo-like) procedure to compare effects.
What are the potential side effects?
Potential side effects from tDCS may include discomfort at the electrode sites on the head, itching, tingling sensations during application, headache after treatment sessions, and fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post treatment (approx at 3 month)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post treatment (approx at 3 month)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neurophysiological impacts as measured by Magnetoencephalography (MEG)
Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI)
Sensorimotor behavior as measured by Grip Strength
+4 moreSecondary study objectives
Executive functioning as measured by Dimensional Card Change Sort
Executive functioning as measured by Flanker Inhibitory Control and Attention
Working memory as measured by Stanford Binet-V Working Memory Subtest
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: transcranial direct current stimulation (tDCS), then sham stimulationExperimental Treatment2 Interventions
Participants receives three weeks of 20-minute tDCS stimulation. After a washout period of 3 months, they then receive three weeks of sham stimulation
Group II: Sham stimulation, then transcranial direct current stimulation (tDCS)Experimental Treatment2 Interventions
Participants receives three weeks of sham stimulation. After a washout period of 3 months, they then receive three weeks of 20-minute tDCS stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham
2013
Completed Phase 3
~2090
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,644 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
60 Patients Enrolled for Autism Spectrum Disorder
Peter Tsai, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
60 Patients Enrolled for Autism Spectrum Disorder